FDA 510(k)

RELIEVA ULTIRRA 鼻腔氣球導管

K 號：K190525 · 2019-05-03

決定日期2019-05-03

產品代碼LRC

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

RELIEVA ULTIRRA Sinus Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190525. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RELIEVA ULTIRRA Sinus Balloon Catheter?

RELIEVA ULTIRRA Sinus Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Acclarent, Inc.. The 510(k) number is K190525.

When did RELIEVA ULTIRRA Sinus Balloon Catheter receive FDA 510(k) clearance?

RELIEVA ULTIRRA Sinus Balloon Catheter received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190525.

Who is the listed applicant for RELIEVA ULTIRRA Sinus Balloon Catheter?

The FDA 510(k) record lists Acclarent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RELIEVA ULTIRRA Sinus Balloon Catheter?

The FDA product code for RELIEVA ULTIRRA Sinus Balloon Catheter is LRC.

其他以 Acclarent, Inc. 為申請人之記錄

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相關器械（代碼：LRC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K230258BB 8 鼻腔擴張組合包Excelent, Inc.K212774文森爾光導設備Intersect Ent.K201398SINUSPRIME 膨脹系統Stryker Ent K201115下一代球囊擴張系統Acclarent, Inc.K201472VenSure 气球設備，VenSure 導航氣球設備Fiagon GmbH K181546迪拉德鼻氣球導管Intuit Medical Products, LLC

官方來源

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